Endometrium protection and acceptability of nasally administered continuously combined hormone therapy: a multicentre, multinational, double-blind trial in post-menopausal women evaluating three regimens of 17ß-estradiol and norethisterone when compared with an orally administered 17ß-estradiol norethisterone regimen  

Oleh:

Rozenberg, Serge ; Pornel, Bruno ; Koninckx, Philippe R. ; Palacios, Santiago ; Christiansen, Claus

Jenis: Article from Journal - ilmiah internasional
Dalam koleksi: Human Reproduction vol. 24 no. 07 (Jul. 2009), page 1739-1747.
Topik: hormone therapy/menopause/intranasal/estradiol/norethisterone

Ketersediaan

Perpustakaan FK Nomor Panggil: H07.K.2009.03 Non-tandon: 1 (dapat dipinjam: 0) Tandon: tidak ada

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Isi artikel

BACKGROUND: To determine the optimal daily dose of intranasal hormone therapy (HT) in order to achieve adequate endometrial protection. METHODS: Multicentre, double-blind/double-dummy randomized controlled trial (Phase III) was conducted in 1741 women to compare a daily intranasal dose of 350 µg 17ß-estradiol (E2) together with 50, 175 or 550 µg norethisterone (NET) with the oral administration of 2 mg E2 and 1 mg NET, over a period of 52 weeks. An endometrial biopsy was performed at the end of HT use. RESULTS: Most women (73–86%) had an ‘atrophic and/or inactive’ endometrium. Lower doses of NET were associated with a higher incidence of ‘proliferative’ endometrium. The incidence of vaginal bleeding decreased with time. During the last 4 months of the study, 88.1% of women using the highest dose of NET were in amenorrhoea when compared with 71.7% using the oral comparator (difference 16.5%; 95% confidence interval: 10.9–22.0%) (P < 0.001). Premature discontinuation rates were in the range of 12–17% for the three nasal regimens and 22% for the oral comparator. CONCLUSIONS: HT using a fixed intranasal dose of 350 µg E2 combined with 550 µg NET is a safe regimen, in relation to 1 year endometrial safety. This regimen is associated with less vaginal bleeding when compared with an oral comparator using 2 mg E2 and 1 mg NET.

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